MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Nausea (1970); Pain (1994); Rash (2033); Shaking/Tremors (2515); Fibrosis (3167); Thrombosis/Thrombus (4440)

Event Date 01/01/2005

Event Type  Injury  

Event Description

Patient called to report an adverse reaction and product issue with her filshie clips she had implanted in 2005.Patient stated she had a tubal in 2005 and requested not to get the filshie clips, however they were put in against her request.Patient stated that after 6 weeks she experienced severe pain, was told by her physician that it was due to fibroids, but that turned out not to be the case.Patient stated she continued to complain about the pain and in 2015, patient experienced bilateral dvt's.Patient stated she had an mri done sometime in either 2017 or 2018 and it was discovered that the clips had migrated, but she hasn't found out where they are located.Patient stated when sitting or lying down, it feels like something is digging into the side of her hip.Patient said she had an allergy test done on (b)(6) 2021 and it was positive for nickel, which the filshie clips contain.Patient stated that due to the allergy and her reaction, she experiences tremors in both hands, rashes, abdominal bloating, and nausea.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12513330
• MDR Text Key: 273092472
• Report Number: MW5104145
• Device Sequence Number: 1
• Product Code: KNH
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR